6.3 Shelf life
Unopened - Three years

For reconstituted solutions, chemical and physical in-use stability has been demonstrated for at least 24 hours at 25°C. From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Following dilution using the fluids detailed in section 6.6, chemical and physical in-use stability has been demonstrated for up to 12 hours at 25°C. From a microbiological point of view the diluted solution should be used immediately. If not used immediately in-use storage times and conditions are the responsibility of the user.

6.4 Special precautions for storage
Unopened: Do not store above 25°C.

Keep the vials in the outer carton.

After reconstitution: Do not store above 25°C (see 6.3 Shelf Life).

6.5 Nature and contents of container
Packs* of one, five or ten Type I colourless glass 10ml vials stoppered with a chlorobutyl stopper and an aluminium and polypropylene flip-off cap.

*Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling
Reconstitution:

Aciclovir 250mg for infusion should be reconstituted using 10ml of either Water for Injections PhEur or Sodium Chloride Intravenous Infusion BP (0.9% w/v) to provide a solution containing 25mg aciclovir per ml.

From the calculated dose, determine the appropriate number and strength of vials to be used. To reconstitute each vial add the recommended volume of infusion fluid and shake gently until the contents of the vial have dissolved completely.

The reconstituted solution appears light yellow and slightly opalescent.

After reconstitution aciclovir powder for solution for infusion may be administered by a controlled-rate infusion pump.

Alternatively, the reconstituted solution may be further diluted to give an aciclovir concentration of not greater than 5 mg/ml (0.5% w/v) for administration by infusion:

For further dilution, add the required volume of reconstituted solution to the chosen infusion solution, as recommended below, and shake well to ensure adequate mixing occurs.

For children and neonates, where it is advisable to keep the volume of infusion fluid to a minimum, it is recommended that dilution is on the basis of 4ml reconstituted solution (100mg aciclovir) added to 20 ml of infusion fluid.

For adults, it is recommended that infusion bags containing 100ml of infusion fluid are used, even when this would give an aciclovir concentration substantially below 0.5% w/v. Thus, one 100 ml infusion bag may be used for any dose between 250mg and 500mg aciclovir (10 and 20 ml of reconstituted solution) but a second bag must be used for doses between 500 and 1000mg.

When diluted in accordance with the recommended schedules, aciclovir for infusion is known to be compatible with the following infusion fluids:

- sodium chloride intravenous infusion BP (0.45% and 0.9% w/v);

- sodium chloride (0.18% w/v) and glucose (4% w/v) intravenous infusion BP

- sodium chloride (0.45% w/v) and glucose (2.5% w/v) intravenous infusion BP

- compound sodium lactate intravenous infusion BP (Hartmann's Solution).

Aciclovir for infusion, when diluted in accordance